First Time Dual Chamber Pacemaker ImplantationPhase 4NCT01805804
Valsartan to Prevent Left Ventricle Remodeling in Pacemaker Patients
A Phase 4 study of First Time Dual Chamber Pacemaker Implantation, run by Medical University of Silesia at 1 site in Poland.
Trial summary
Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First Time Dual Chamber Pacemaker Implantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2017to 31 Jan 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed written consent
- age ≥ 18 years
- first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block
- left ventricle ejection fraction ≥ 40%
Who cannot join
- significant valvular heart disease
- ischaemic heart disease requiring further revascularization
- symptomatic hypotension
- orthostatic disorders
- pregnancy, breast feeding, child bearing potential
- previous use of angiotensin receptor blocking agents
Show all 16Show fewer
- known hypersensitivity to valsartan
- significant liver disorders
- significant renal disorders, including renal artery stenosis
- hyperaldosteronism
- chronic use of nonsteroid antiinflammatory drugs
- chronic use of lithium salts
- Patient's reluctance or disability to obey protocol and/or follow the scheduled visits
- any significant disease to reduce the expected life duration < 12 months
- participation in any other trial within the last 30 days before randomization
- any situation that would put more risk on patient
Trial locations and contacts
1 site in 1 country.
Poland1 site
II Dept. of Cardiology in Zabrze Medical University of Silesia
Zabrze, Upper Silesia, 41-800
About this study
Official title: Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker
Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. Echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and distance in meters during six minute walking test.
- Being tested
- placebo/valsartan
- Keywords
- dual chamber pacing, left ventricle remodeling, valsartan
- Medical subject headings
- Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo/valsartanDrug
Also called Valsartan, Other names:, Diovan, Axudan
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pills to match valsartan tablets administered once daily Receives: Drug: placebo/valsartan |
| valsartan 80mg daily | Experimental | Valsartan 80mg tablet once daily Receives: Drug: placebo/valsartan |
| valsartan 160mg daily | Experimental | Valsartan 160mg tablet once daily Receives: Drug: placebo/valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in echocardiographically assessed left ventricle dimensions and left ventricle function
Measured: baseline and 12 months
Secondary outcomes (7)
change in plasma level of matrix metalloproteinase 9
Measured: baseline and 12 months
change in plasma level of NTproBNP
Measured: baseline and 12 months
change in atrial arrhythmia burden assessed from pacemaker memory
Measured: baseline and 12 months
change in the rate of occurrence of any major adverse cardiovascular event
Measured: 2 weeks, 3 months, 6 months, 9 months and 12 months
change in plasma level of tissue necrosis factor alpha
Measured: baseline and 12 months
change in plasma level of tissue inhibitor of matrix metalloproteinase 3
Measured: baseline and 12 months
change in distance walked during six minute walking test
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startJan 2017
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Why it stopped: Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for First Time Dual Chamber Pacemaker ImplantationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Polpharma Pharmaceutical Company
- Responsible party
- Principal investigator, Andrzej Tomasik MD PhD FESC, Medical University of Silesia
- Investigators
- Ewa Nowalany-Kozielska, MD PhD Associate Professor, Study director, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805804
- Sponsor's protocol ID
- 01/2012
- Other IDs
- KNW-1-154/P/2/0
- Status last verified
- Apr 2023
- First submitted
- 2 Mar 2013
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Suzuki H, Geshi E, Nanjyo S, Nakano H, Yamazaki J, Sato N, Tanaka K, Takano T, Yagi H, Shibata T, Mochizuki S, Katagiri T. Inhibitory effect of valsartan against progression of left ventricular dysfunction after myocardial infarction: T-VENTURE study. Circ J. 2009 May;73(5):918-24. doi: 10.1253/circj.cj-08-0959. Epub 2009 Apr 2.
PubMed 19346662Miyazaki S, Kasai T, Miyauchi K, Miyazaki T, Akimoto Y, Takagi A, Aihara K, Kawamura M, Suwa S, Kojima S, Sumiyoshi M, Daida H. Changes of matrix metalloproteinase-9 level is associated with left ventricular remodeling following acute myocardial infarction among patients treated with trandolapril, valsartan or both. Circ J. 2010 Jun;74(6):1158-64. doi: 10.1253/circj.cj-09-0412. Epub 2010 Apr 6.
PubMed 20378999Garcia RA, Brown KL, Pavelec RS, Go KV, Covell JW, Villarreal FJ. Abnormal cardiac wall motion and early matrix metalloproteinase activity. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1080-7. doi: 10.1152/ajpheart.00860.2004. Epub 2004 Oct 14.
PubMed 15486029Tomasik A, Jachec W, Wojciechowska C, Kawecki D, Bialkowska B, Romuk E, Gabrysiak A, Birkner E, Kalarus Z, Nowalany-Kozielska E. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial. Contemp Clin Trials. 2015 May;42:239-43. doi: 10.1016/j.cct.2015.03.015. Epub 2015 Apr 7.
PubMed 25858003
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo Controlled Blinded Study to Assess the Efficacy of Valsartan to Prevent Left Ventricle Remodeling in Patients With Dual Chamber Pacemaker
- ClinicalTrials.gov ID
- NCT01805804
- Acronym / sponsor ID
- 01/2012
- Keywords
- dual chamber pacing, left ventricle remodeling, valsartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well.
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Polpharma Pharmaceutical Company
- Study start
- Jan 2017
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 6 Mar 2013 (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.
Dual chamber pacing is known to induce left ventricle remodeling and may eventually lead to heart failure. The investigators aim to test hypothesis that valsartan started immediately after dual chamber pacemaker implantation will prevent left ventricle remodeling in twelve months long follow up in comparison with placebo. Echocardiographic assessment of left ventricle remodeling will be correlated with plasma activity of matrix metalloproteinases and their tissue inhibitors, indices of functional capacity such as plasma level of NTproBNP and distance in meters during six minute walking test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo/valsartanPlacebo pills to match valsartan tablets administered once daily |
| valsartan 80mg daily | Experimental | Drug: placebo/valsartanValsartan 80mg tablet once daily |
| valsartan 160mg daily | Experimental | Drug: placebo/valsartanValsartan 160mg tablet once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed written consent
- age ≥ 18 years
- first time pacemaker implantation for trifascicular block, atrioventricular second or third degree block
- left ventricle ejection fraction ≥ 40%
Key exclusion criteria (16 listed)
- significant valvular heart disease
- ischaemic heart disease requiring further revascularization
- symptomatic hypotension
- orthostatic disorders
- pregnancy, breast feeding, child bearing potential
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 |
|---|---|---|
| placebo/valsartanAlso: Valsartan, Other names:, Diovan, Axudan | Drug | Placebo, valsartan 160mg daily, valsartan 80mg daily |
Primary outcome
change in echocardiographically assessed left ventricle dimensions and left ventricle function
Time frame: baseline and 12 months
7 secondary outcomes
change in plasma level of matrix metalloproteinase 9
Time frame: baseline and 12 months
change in plasma level of NTproBNP
Time frame: baseline and 12 months
change in atrial arrhythmia burden assessed from pacemaker memory
Time frame: baseline and 12 months
change in the rate of occurrence of any major adverse cardiovascular event
Time frame: 2 weeks, 3 months, 6 months, 9 months and 12 months
change in plasma level of tissue necrosis factor alpha
Time frame: baseline and 12 months
change in plasma level of tissue inhibitor of matrix metalloproteinase 3
Time frame: baseline and 12 months
change in distance walked during six minute walking test
Time frame: baseline and 12 months
Results and safety
The study was stopped early (reason given: Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 19346662Suzuki H, Geshi E, Nanjyo S, Nakano H, Yamazaki J, Sato N, Tanaka K, Takano T, Yagi H, Shibata T, Mochizuki S, Katagiri T. Inhibitory effect of valsartan against progression of left ventricular dysfunction after myocardial infarction: T-VENTURE study. Circ J. 2009 May;73(5):918-24. doi: 10.1253/circj.cj-08-0959. Epub 2009 Apr 2.
- Background: PubMed 20378999Miyazaki S, Kasai T, Miyauchi K, Miyazaki T, Akimoto Y, Takagi A, Aihara K, Kawamura M, Suwa S, Kojima S, Sumiyoshi M, Daida H. Changes of matrix metalloproteinase-9 level is associated with left ventricular remodeling following acute myocardial infarction among patients treated with trandolapril, valsartan or both. Circ J. 2010 Jun;74(6):1158-64. doi: 10.1253/circj.cj-09-0412. Epub 2010 Apr 6.
- Background: PubMed 15486029Garcia RA, Brown KL, Pavelec RS, Go KV, Covell JW, Villarreal FJ. Abnormal cardiac wall motion and early matrix metalloproteinase activity. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1080-7. doi: 10.1152/ajpheart.00860.2004. Epub 2004 Oct 14.
- Derived from this study: PubMed 25858003Tomasik A, Jachec W, Wojciechowska C, Kawecki D, Bialkowska B, Romuk E, Gabrysiak A, Birkner E, Kalarus Z, Nowalany-Kozielska E. Randomized placebo controlled blinded study to assess valsartan efficacy in preventing left ventricle remodeling in patients with dual chamber pacemaker--Rationale and design of the trial. Contemp Clin Trials. 2015 May;42:239-43. doi: 10.1016/j.cct.2015.03.015. Epub 2015 Apr 7.
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.
Ewa Nowalany-Kozielska, MD PhD Associate Professor study director
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of First Time Dual Chamber Pacemaker Implantation, run by Medical University of Silesia at 1 site in Poland.
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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Recall of some valsartan preparations. 88 patients enrolled and completed the observation. All patients are in continuous observation and are well.). Results are not available in the source record.
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 echocardiographically assessed left ventricle dimensions and left ventricle function (time frame: baseline and 12 months). 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 NCT01805804, which also lists 4 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 12 Apr 2023.