Heart Failure NYHA Class IVNCT04218435
Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients
An observational study of Heart Failure NYHA Class IV and Heart Failure NYHA Class II, run by Clinision at 1 site in Pakistan.
Trial summary
The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure NYHA Class IV, Heart Failure NYHA Class II
- What is being tested?
- Sacubitril / Valsartan Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 30 Dec 2020
- Phase
- Observational
- 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 70 years
- All sexes
- Adult, Older adult
Study population: 130 patients of heart failure with NYHA (II-IV)
Who may be able to join
- Patients with heart failure (NYHA class II-IV).
- LV EF(less than or equal to 40%).
- eGFR (more than 30 ml/min /1.73m2).
Who cannot join
- Symptomatic hypotension.
- eGFR<30 ml/min/1.73m2 .
- Serum potassium >5.2mmol/L
- Angioedema
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Doctors hospital and medical center
Lahore, Punjab Province, 54590
About this study
The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering
Read the detailed description
Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).
- Being tested
- Sacubitril / Valsartan Oral Tablet
- Keywords
- chronickindeydisease, qualityoflife
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril / Valsartan Oral TabletDrug
Also called Sacvin
Sacubitril/Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
Sacubitril/Valsartan is usually administered in conjunction with another heart failure therapies, in place of an ACE inhibitor or other ARB.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Sacubitril/valsartan is a combination of a neprilysin inhibitor, sacubitril and an angiotensin II receptor blocker, valsartan.
The recommended starting dose is one 49/51 mg (sacubitril/valsartan) tablet twice-daily. Double the dose of Sacubitril/valsartan after 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient.
Reduce the starting dose to 24/26 mg (sacubitril/valsartan) twice-daily for:
* Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
* Patients with severe renal impairment (CrCl less than 30 ml/min)
* Patients with moderate hepatic impairment. (Child Pugh B) Double the dose of Sacubitril/valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient Receives: Drug: Sacubitril / Valsartan Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire
comparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan
Measured: 1 year
Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire
Improvement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan.
Measured: 1 year
Secondary outcomes (1)
Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor
changes in the baseline of acute kidney injury, electrolyte imbalance and hemodynamic instability before and after taking treatment of sacubitril valsartan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Jan 2019
- Primary completion25 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IVStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinision
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahryar Shiekh, Principal investigator, Doctors hospital and Medical center, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218435
- Sponsor's protocol ID
- PK/IIS/001
- Status last verified
- Oct 2019
- First submitted
- 27 Dec 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04218435
- Acronym / sponsor ID
- PK/IIS/001
- Keywords
- chronickindeydisease, qualityoflife
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ClinisionUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 6 Jan 2020 (actual)
- 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.
The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering
Detailed description
Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Drug: Sacubitril / Valsartan Oral TabletSacubitril/valsartan is a combination of a neprilysin inhibitor, sacubitril and an angiotensin II receptor blocker, valsartan. The recommended starting dose is one 49/51 mg (sacubitril/valsartan) tablet twice-daily. Double the dose of Sacubitril/valsartan after 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient. Reduce the starting dose to 24/26 mg (sacubitril/valsartan) twice-daily for: * Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. * Patients with severe renal impairment (CrCl less than 30 ml/min) * Patients with moderate hepatic impairment. (Child Pugh B) Double the dose of Sacubitril/valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 130 patients of heart failure with NYHA (II-IV)
Key inclusion criteria (3 listed)
- Patients with heart failure (NYHA class II-IV).
- LV EF(less than or equal to 40%).
- eGFR (more than 30 ml/min /1.73m2).
Key exclusion criteria (4 listed)
- Symptomatic hypotension.
- eGFR<30 ml/min/1.73m2 .
- Serum potassium >5.2mmol/L
- Angioedema
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 |
|---|---|---|
| Sacubitril / Valsartan Oral TabletAlso: SacvinSacubitril/Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. Sacubitril/Valsartan is usually administered in conjunction with another heart failure therapies, in place of an ACE inhibitor or other ARB. | Drug | Observational |
Primary outcome
Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire
Time frame: 1 year
comparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan
Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire
Time frame: 1 year
Improvement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan.
1 secondary outcome
Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor
Time frame: 1 year
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 1 Feb 2021.
Related trials for Heart Failure NYHA Class IV
Not yet recruiting
Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
Heart Failure, Heart Failure New York Heart Association Class III
Active, not recruitingObservational study
Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
Heart Failure, Heart Failure NYHA Class IV
Active, not recruiting
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Heart Failure, Heart Failure NYHA Class III
RecruitingPhase 1
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
Univentricular Heart, Congenital Heart Disease
Recruiting
Sustaining Home Heart Failure Palliative Care in Rural Appalachia
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
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.
Shahryar Shiekh principal investigator
Doctors hospital and Medical center, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure NYHA Class IV and Heart Failure NYHA Class II, run by Clinision at 1 site in Pakistan.
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 3 inclusion and 4 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 1 Feb 2021. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2021.