Heart Failure, DiastolicPhase 3BADDHYNCT00820352
Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension
A Phase 3 study testing bosentan in people with Heart Failure, Diastolic and Hypertension, Pulmonary, run by University Teaching Hospital Hall in Tirol at 7 sites in Austria.
Trial summary
Heart failure is a major medical and socioeconomic problem in western industrial countries, especially with aging populations. Heart failure with normal left ventricle systolic function (heart failure with preserved ejection fraction, HFPEF, heart failure with normal ejection fraction, HFNEF) are common causes of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Diastolic, Hypertension, Pulmonary
- What is being tested?
- bosentan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 7 sitesAustria
- Study dates
- Jan 2009to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically signs or history of congestive heart failure NYHA II-III (Fatigue, dyspnea on exertion, lung crepitations, pulmonary edema, ankle and or lower leg swelling, jugular pressure enhancement, hepatomegaly)
- Echocardiographic signs of diastolic dysfunction (heart failure with normal ejection fraction)
- Right ventricle enlargement with pulmonary hypertension
- 6 minute walking distance > 150 m < 400 m
- Right Heart Catheterization: Mean PAP > 25 mmHg, PCWP > 15 mmHg
- Echocardiographic requirements for definition of heart failure with normal ejection fraction
Show all 20Show fewer
- E/E' > 15, or
- E/E' > 8 + NTpBNP > 220 pg/ml, or
- E/E' > 8 + E:A < 0.5 + DT > 280 ms or
- Ard-Ad > 30 ms or
- atrial enlargement or
- atrial fibrillation
- NTpBNP > 220 pg/ml + combination
- IVRT - IVRTm < 0 septal und lateral
- Echocardiographic requirements for pulmonary hypertension and right ventricle dysfunction
- RVEDD > 30 mm short axis parasternal, and
- one of the following:
- Tricuspid valve regurgitation velocity (TRV) > 3 m/s;
- RV-annular systolic velocity < 10 cm/sec (TDI)
- TAPSE < 18 mm
Who cannot join
- Patients who are not on guideline conform treatments for cardiovascular disease.
- Left ventricle systolic dysfunction (EF < 50 %), aortic stenosis with peak gradient (instantane) > 40 mm Hg,moderate and severe aortic insufficiency
- moderate and severe mitral regurgitation,
- acute coronary disease, stable coronary artery disease or peripheral vascular disease limiting exercise.
- Other causes of pulmonary - artery - hypertension:
- relevant obstructive ventilatory disease > grade II (lung functions tests)
Show all 18Show fewer
- collagen disease (Tests: MSCT and ANA, ANCA),
- chronic thrombo- embolic pulmonary arterial hypertension (MSCT),
- sleep disorder.
- HIV, HCV, HBV infection.
- Drug related PAH.
- Orthopaedic disease, immobility, inability to perform 6MWT and cancer.
- Liver disease Child-Pugh B and C, three fold above normal elevated liver enzymes,
- anaemia Hb < 10 mg/dl,
- other specific treatment of pulmonary arterial hypertension including other endothelin receptor blockers, phosphodiesterase inhibitors, prostaglandins and L-arginin
- drug therapy with glibenclamide, rifampicin, tacrolimus, sirolimus, cyclosporine A
- known adverse reactions to bosentan and
- pregnancy and lactation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Austria7 sites
University Teaching Hospital Hall i.T.
Hall I. T., Tyrol, 6060
Hospital Hohenems
Hohenems, 6845
University Teaching Hospital of the Elisabethinen, Linz
Linz, Upper Austria, 4010
Hospital Natters
Natters, 6161
University Hospital Salzburg
Salzburg, 5020
Hospital Mostviertel Waidhofen/Ybbs
Waidhofen an der Thaya, Lower Austria, 3340
Hospital Wels/Grieskirchen
Wels, Upper Austria, 4600
About this study
Official title: Endothelin Receptor Blockade in Heart Failure With Diastolic Dysfunction and Pulmonary Hypertension
Heart failure is a major medical and socioeconomic problem in western industrial countries, especially with aging populations. Heart failure with normal left ventricle systolic function (heart failure with preserved ejection fraction, HFPEF, heart failure with normal ejection fraction, HFNEF) are common causes of hospitalization mainly in the elderly population and are frequently associated with pulmonary hypertension. It is commonly seen, that patients with left heart disease and pulmonary hypertension with right ventricle dysfunction have a worse prognosis.
The investigators hypothesize, that an additional treatment with Bosentan in this patients will improve their exercise capacity, symptoms, hemodynamics and quality of life.
Read the detailed description
Heart Failure with preserved ejection fraction is with more than 50% of cases the most common form of heart failure. Typically patients are elderly women with arterial hypertension. Mortality, hospitalization rates due to heart failure and in-hospital complications do not differ significantly from patients with systolic heart failure. However there are some subgroups of HFPEF-patients with a worse prognosis, for example up to 30% of patients develop secondary pulmonary hypertension and thus right ventricle dysfunction. Increased right-ventricle systolic pressure is associated with increased mortality in patients with all forms of heart failure.
There is a lack of evidence about HFPEF. Drugs for treating systolic heart failure showed no improvement in mortality and prognosis. Diuretics are just able to relieve symptoms. There are no clinical trials concerning HFPEF with secondary pulmonary hypertension.
The endothelin system is not only activated in PAH, but also in pulmonary venous hypertension and congestive heart failure, where ET-1 levels rise with the severity of secondary pulmonary hypertension. Pulmonary congestion leads to endothelial dysfunction that results in increased levels of Endothelin-1 (ET-1).
ET-1 is a potent vasoconstrictor. In pulmonary arterial vessels the ETA receptor is the predominant receptor (ratio of ETA to ET B = 9:1), which is responsible for vasoconstriction and remodeling of the pulmonal vasculature. In heart failure the ETA receptor is upregulated. Elevated plasma ET-1 levels correlate with pulmonary artery pressure (PAP), pulmonary vascular resistance (PVR) and inversely with peak exercise capacity.
Recent clinical and laboratory findings indicate comparable pathophysiological mechanisms in pulmonary hypertension secondary to left ventricular dysfunction and pulmonary arterial hypertension. Yet, despite an expanding application in pulmonary artery hypertension, according to current opinion, the oral dual endothelin (ETA/ETB) antagonist bosentan is not indicated for PVH caused by left ventricle / left atrial pressure overload and preserved systolic function. However, there are several studies which show some effects of pulmonary vessel dilating drugs in PAH and left ventricle dysfunction.
- Conditions
- Heart Failure, Diastolic, Hypertension, Pulmonary
- Being tested
- bosentan, placebo
- Keywords
- HFNEF, HFPEF, Secondary Pulmonary Hypertension, Endothelin Receptor Blockade
- Medical subject headings
- Heart Failure, Diastolic, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
Also called Ro 47.0203
4 weeks of oral bosentan 62,5 mg b.i.d., followed by 8 weeks of 125 mg b.i.d.
placeboDrug
placebo twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| bosentan | Active comparator | Patients in this arm receive bosentan twice a day for 12 weeks Receives: Drug: bosentan |
| placebo | Placebo comparator | patients in this arm receive 12 placebo twice a day for 12 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 6 minute waling distance after 12 weeks of bosentan (or placebo) treatment
Measured: 12 weeks
Secondary outcomes (6)
change in 6 minute walking distance after 24 weeks (12 weeks bosentan or placebo treatment and 12 weeks follow-up)
Measured: 24 weeks
changes in hemodynamics assessed by echocardiography after 12 and 24 weeks
Measured: 24 weeks
time to clinical worsening after 12 and 24 weeks
Measured: 24 weeks
levels of NTpBNP, CRP and Endothelin-1 after 12 and 24 weeks
Measured: 24 weeks
Quality of Life assessment (SF-36 and Minnesota Living With Heart Failure Score) after 12 and 24 weeks
Measured: 24 weeks
Adverse event count after 12 and 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Teaching Hospital Hall in Tirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilhelm Grander, M.D., University Teaching Hospital Hall in Tirol
- Investigators
- Wilhelm Grander, M.D., Principal investigator, University Teaching Hospital Hall i.T.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820352
- Sponsor's protocol ID
- BO-001
- Other IDs
- EUDRACT Number: 2008-005514-40
- Acronym
- BADDHY
- Status last verified
- Jun 2014
- First submitted
- 8 Jan 2009
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kjaergaard J, Akkan D, Iversen KK, Kjoller E, Kober L, Torp-Pedersen C, Hassager C. Prognostic importance of pulmonary hypertension in patients with heart failure. Am J Cardiol. 2007 Apr 15;99(8):1146-50. doi: 10.1016/j.amjcard.2006.11.052. Epub 2007 Mar 8.
PubMed 17437745Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
PubMed 16855265Shah SJ, Gheorghiade M. Heart failure with preserved ejection fraction: treat now by treating comorbidities. JAMA. 2008 Jul 23;300(4):431-3. doi: 10.1001/jama.300.4.431. No abstract available.
PubMed 18647986Sanderson JE. Heart failure with a normal ejection fraction. Heart. 2007 Feb;93(2):155-8. doi: 10.1136/hrt.2005.074187. Epub 2005 Dec 30.
PubMed 16387829Yip GW, Wang M, Wang T, Chan S, Fung JW, Yeung L, Yip T, Lau ST, Lau CP, Tang MO, Yu CM, Sanderson JE. The Hong Kong diastolic heart failure study: a randomised controlled trial of diuretics, irbesartan and ramipril on quality of life, exercise capacity, left ventricular global and regional function in heart failure with a normal ejection fraction. Heart. 2008 May;94(5):573-80. doi: 10.1136/hrt.2007.117978. Epub 2008 Jan 20.
PubMed 18208835Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, Gong Y, Liu PP. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med. 2006 Jul 20;355(3):260-9. doi: 10.1056/NEJMoa051530.
PubMed 16855266Bursi F, Weston SA, Redfield MM, Jacobsen SJ, Pakhomov S, Nkomo VT, Meverden RA, Roger VL. Systolic and diastolic heart failure in the community. JAMA. 2006 Nov 8;296(18):2209-16. doi: 10.1001/jama.296.18.2209.
PubMed 17090767Tribouilloy C, Rusinaru D, Mahjoub H, Souliere V, Levy F, Peltier M, Slama M, Massy Z. Prognosis of heart failure with preserved ejection fraction: a 5 year prospective population-based study. Eur Heart J. 2008 Feb;29(3):339-47. doi: 10.1093/eurheartj/ehm554. Epub 2007 Dec 22.
PubMed 18156618Sweitzer NK, Lopatin M, Yancy CW, Mills RM, Stevenson LW. Comparison of clinical features and outcomes of patients hospitalized with heart failure and normal ejection fraction (> or =55%) versus those with mildly reduced (40% to 55%) and moderately to severely reduced (<40%) fractions. Am J Cardiol. 2008 Apr 15;101(8):1151-6. doi: 10.1016/j.amjcard.2007.12.014. Epub 2008 Feb 20.
PubMed 18394450Onishi K, Ohno M, Little WC, Cheng CP. Endogenous endothelin-1 depresses left ventricular systolic and diastolic performance in congestive heart failure. J Pharmacol Exp Ther. 1999 Mar;288(3):1214-22.
PubMed 10027861Moraes DL, Colucci WS, Givertz MM. Secondary pulmonary hypertension in chronic heart failure: the role of the endothelium in pathophysiology and management. Circulation. 2000 Oct 3;102(14):1718-23. doi: 10.1161/01.cir.102.14.1718.
PubMed 11015353Lewis GD, Shah R, Shahzad K, Camuso JM, Pappagianopoulos PP, Hung J, Tawakol A, Gerszten RE, Systrom DM, Bloch KD, Semigran MJ. Sildenafil improves exercise capacity and quality of life in patients with systolic heart failure and secondary pulmonary hypertension. Circulation. 2007 Oct 2;116(14):1555-62. doi: 10.1161/CIRCULATIONAHA.107.716373. Epub 2007 Sep 4.
PubMed 17785618Galie N, Manes A, Branzi A. The endothelin system in pulmonary arterial hypertension. Cardiovasc Res. 2004 Feb 1;61(2):227-37. doi: 10.1016/j.cardiores.2003.11.026.
PubMed 14736539Cowburn PJ, Cleland JG. Endothelin antagonists for chronic heart failure: do they have a role? Eur Heart J. 2001 Oct;22(19):1772-84. doi: 10.1053/euhj.2000.2557. No abstract available.
PubMed 11549299Cowburn PJ, Cleland JG, McDonagh TA, McArthur JD, Dargie HJ, Morton JJ. Comparison of selective ET(A) and ET(B) receptor antagonists in patients with chronic heart failure. Eur J Heart Fail. 2005 Jan;7(1):37-42. doi: 10.1016/j.ejheart.2004.08.001.
PubMed 15642529
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelin Receptor Blockade in Heart Failure With Diastolic Dysfunction and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00820352
- Acronym / sponsor ID
- BADDHY / BO-001
- Conditions
- Heart Failure, Diastolic, Hypertension, Pulmonary
- Keywords
- HFNEF, HFPEF, Secondary Pulmonary Hypertension, Endothelin Receptor Blockade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Teaching Hospital Hall in TirolUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure is a major medical and socioeconomic problem in western industrial countries, especially with aging populations. Heart failure with normal left ventricle systolic function (heart failure with preserved ejection fraction, HFPEF, heart failure with normal ejection fraction, HFNEF) are common causes of hospitalization mainly in the elderly population and are frequently associated with pulmonary hypertension. It is commonly seen, that patients with left heart disease and pulmonary hypertension with right ventricle dysfunction have a worse prognosis.
The investigators hypothesize, that an additional treatment with Bosentan in this patients will improve their exercise capacity, symptoms, hemodynamics and quality of life.
Detailed description
Heart Failure with preserved ejection fraction is with more than 50% of cases the most common form of heart failure. Typically patients are elderly women with arterial hypertension. Mortality, hospitalization rates due to heart failure and in-hospital complications do not differ significantly from patients with systolic heart failure. However there are some subgroups of HFPEF-patients with a worse prognosis, for example up to 30% of patients develop secondary pulmonary hypertension and thus right ventricle dysfunction. Increased right-ventricle systolic pressure is associated with increased mortality in patients with all forms of heart failure.
There is a lack of evidence about HFPEF. Drugs for treating systolic heart failure showed no improvement in mortality and prognosis. Diuretics are just able to relieve symptoms. There are no clinical trials concerning HFPEF with secondary pulmonary hypertension.
The endothelin system is not only activated in PAH, but also in pulmonary venous hypertension and congestive heart failure, where ET-1 levels rise with the severity of secondary pulmonary hypertension. Pulmonary congestion leads to endothelial dysfunction that results in increased levels of Endothelin-1 (ET-1).
ET-1 is a potent vasoconstrictor. In pulmonary arterial vessels the ETA receptor is the predominant receptor (ratio of ETA to ET B = 9:1), which is responsible for vasoconstriction and remodeling of the pulmonal vasculature. In heart failure the ETA receptor is upregulated. Elevated plasma ET-1 levels correlate with pulmonary artery pressure (PAP), pulmonary vascular resistance (PVR) and inversely with peak exercise capacity.
Recent clinical and laboratory findings indicate comparable pathophysiological mechanisms in pulmonary hypertension secondary to left ventricular dysfunction and pulmonary arterial hypertension. Yet, despite an expanding application in pulmonary artery hypertension, according to current opinion, the oral dual endothelin (ETA/ETB) antagonist bosentan is not indicated for PVH caused by left ventricle / left atrial pressure overload and preserved systolic function. However, there are several studies which show some effects of pulmonary vessel dilating drugs in PAH and left ventricle dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bosentan | Active comparator | Drug: bosentanPatients in this arm receive bosentan twice a day for 12 weeks |
| placebo | Placebo comparator | Drug: placebopatients in this arm receive 12 placebo twice a day for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Clinically signs or history of congestive heart failure NYHA II-III (Fatigue, dyspnea on exertion, lung crepitations, pulmonary edema, ankle and or lower leg swelling, jugular pressure enhancement, hepatomegaly)
- Echocardiographic signs of diastolic dysfunction (heart failure with normal ejection fraction)
- Right ventricle enlargement with pulmonary hypertension
- 6 minute walking distance > 150 m < 400 m
- Right Heart Catheterization: Mean PAP > 25 mmHg, PCWP > 15 mmHg
Key exclusion criteria (18 listed)
- Patients who are not on guideline conform treatments for cardiovascular disease.
- Left ventricle systolic dysfunction (EF < 50 %), aortic stenosis with peak gradient (instantane) > 40 mm Hg,moderate and severe aortic insufficiency
- moderate and severe mitral regurgitation,
- acute coronary disease, stable coronary artery disease or peripheral vascular disease limiting exercise.
- Other causes of pulmonary - artery - hypertension:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bosentanAlso: Ro 47.02034 weeks of oral bosentan 62,5 mg b.i.d., followed by 8 weeks of 125 mg b.i.d. | Drug | bosentan |
| placeboplacebo twice a day for 12 weeks | Drug | placebo |
Primary outcome
change in 6 minute waling distance after 12 weeks of bosentan (or placebo) treatment
Time frame: 12 weeks
6 secondary outcomes
change in 6 minute walking distance after 24 weeks (12 weeks bosentan or placebo treatment and 12 weeks follow-up)
Time frame: 24 weeks
changes in hemodynamics assessed by echocardiography after 12 and 24 weeks
Time frame: 24 weeks
time to clinical worsening after 12 and 24 weeks
Time frame: 24 weeks
levels of NTpBNP, CRP and Endothelin-1 after 12 and 24 weeks
Time frame: 24 weeks
Quality of Life assessment (SF-36 and Minnesota Living With Heart Failure Score) after 12 and 24 weeks
Time frame: 24 weeks
Adverse event count after 12 and 24 weeks
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Background: PubMed 17437745Kjaergaard J, Akkan D, Iversen KK, Kjoller E, Kober L, Torp-Pedersen C, Hassager C. Prognostic importance of pulmonary hypertension in patients with heart failure. Am J Cardiol. 2007 Apr 15;99(8):1146-50. doi: 10.1016/j.amjcard.2006.11.052. Epub 2007 Mar 8.
- Background: PubMed 16855265Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
- Background: PubMed 18647986Shah SJ, Gheorghiade M. Heart failure with preserved ejection fraction: treat now by treating comorbidities. JAMA. 2008 Jul 23;300(4):431-3. doi: 10.1001/jama.300.4.431. No abstract available.
- Background: PubMed 16387829Sanderson JE. Heart failure with a normal ejection fraction. Heart. 2007 Feb;93(2):155-8. doi: 10.1136/hrt.2005.074187. Epub 2005 Dec 30.
- Background: PubMed 18208835Yip GW, Wang M, Wang T, Chan S, Fung JW, Yeung L, Yip T, Lau ST, Lau CP, Tang MO, Yu CM, Sanderson JE. The Hong Kong diastolic heart failure study: a randomised controlled trial of diuretics, irbesartan and ramipril on quality of life, exercise capacity, left ventricular global and regional function in heart failure with a normal ejection fraction. Heart. 2008 May;94(5):573-80. doi: 10.1136/hrt.2007.117978. Epub 2008 Jan 20.
- Background: PubMed 16855266Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, Gong Y, Liu PP. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med. 2006 Jul 20;355(3):260-9. doi: 10.1056/NEJMoa051530.
- Background: PubMed 17090767Bursi F, Weston SA, Redfield MM, Jacobsen SJ, Pakhomov S, Nkomo VT, Meverden RA, Roger VL. Systolic and diastolic heart failure in the community. JAMA. 2006 Nov 8;296(18):2209-16. doi: 10.1001/jama.296.18.2209.
- Background: PubMed 18156618Tribouilloy C, Rusinaru D, Mahjoub H, Souliere V, Levy F, Peltier M, Slama M, Massy Z. Prognosis of heart failure with preserved ejection fraction: a 5 year prospective population-based study. Eur Heart J. 2008 Feb;29(3):339-47. doi: 10.1093/eurheartj/ehm554. Epub 2007 Dec 22.
- Background: PubMed 18394450Sweitzer NK, Lopatin M, Yancy CW, Mills RM, Stevenson LW. Comparison of clinical features and outcomes of patients hospitalized with heart failure and normal ejection fraction (> or =55%) versus those with mildly reduced (40% to 55%) and moderately to severely reduced (<40%) fractions. Am J Cardiol. 2008 Apr 15;101(8):1151-6. doi: 10.1016/j.amjcard.2007.12.014. Epub 2008 Feb 20.
- Background: PubMed 10027861Onishi K, Ohno M, Little WC, Cheng CP. Endogenous endothelin-1 depresses left ventricular systolic and diastolic performance in congestive heart failure. J Pharmacol Exp Ther. 1999 Mar;288(3):1214-22.
- Background: PubMed 11015353Moraes DL, Colucci WS, Givertz MM. Secondary pulmonary hypertension in chronic heart failure: the role of the endothelium in pathophysiology and management. Circulation. 2000 Oct 3;102(14):1718-23. doi: 10.1161/01.cir.102.14.1718.
- Background: PubMed 17785618Lewis GD, Shah R, Shahzad K, Camuso JM, Pappagianopoulos PP, Hung J, Tawakol A, Gerszten RE, Systrom DM, Bloch KD, Semigran MJ. Sildenafil improves exercise capacity and quality of life in patients with systolic heart failure and secondary pulmonary hypertension. Circulation. 2007 Oct 2;116(14):1555-62. doi: 10.1161/CIRCULATIONAHA.107.716373. Epub 2007 Sep 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilhelm Grander, M.D. principal investigator
University Teaching Hospital Hall i.T.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bosentan in people with Heart Failure, Diastolic and Hypertension, Pulmonary, run by University Teaching Hospital Hall in Tirol at 7 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in 6 minute waling distance after 12 weeks of bosentan (or placebo) treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820352, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.