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Heart Failure, SystolicPhase 4NCT05387967

Safety and Tolerability of Sacubitril/Valsartan in Heart Failure Patient With Reduced Ejection Fraction

A Phase 4 study testing Sacubitril/valsartan in people with Heart Failure, Systolic, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This proof-of-concept, open-label non-randomized clinical trial was conducted at a tertiary care cardiac center in Karachi, Pakistan. Patients with HFrEF were prescribed Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Systolic
What is being tested?
Sacubitril/valsartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 sitePakistan
Study dates
1 Jan 2021to 30 Sep 2021
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Either gender
  • between 18 to 80 years of age
  • Diagnosed with Heart failure with reduced ejection fraction (HFrEF)
  • New York Heart Association (NYHA) class II-IV
  • Left ventricular ejection fraction (LVEF) ≤ 40%
  • Stable on any dose of beta-blockers, ACEI or ARB

Who cannot join

  • Refused to participate in the study
  • Patients with hyperkalemia
  • Patients with hypotension
  • Patients with renal dysfunction
  • History of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • National Institute of Cardiovascular Diseases

    Karachi, Sindh, 75510

Other trials in Pakistan

About this study

This proof-of-concept, open-label non-randomized clinical trial was conducted at a tertiary care cardiac center in Karachi, Pakistan. Patients with HFrEF were prescribed Sacubitril/Valsartan and followed for 12 weeks for the assessment of safety and tolerability. Safety measures included incidence of hypotension, renal dysfunction, hyperkalemia, and angioedema

Read the detailed description

A required number of consecutive patients meeting the inclusion criteria were recruited for this study. After written informed consent patient demographic and baseline clinical characteristics were obtained. Inclusion criteria for the study were either gender between 18 to 80 years of age, diagnosed with congestive heart failure (CHF) with NYHA class II-IV, and LVEF ≤ 40%. Pre-inclusion safety parameters were patients who were stable on any dose of beta-blockers, angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) prior to enrolment in the study. Patients with a baseline diagnosis of Hyperkalemia, hypotension, renal dysfunction, and a history of hypersensitivity to the active substances, Sacubitril/Valsartan, or to any of the excipients or drugs of similar chemical classes were excluded from the study.

All the recruited patients were prescribed Sacubitril/Valsartan 100mg/200mg twice a day (BID) for 6 weeks. A weekly telephonic follow-up was made to assess the patient's medication adherence level using the Dose-Nonadherence scale. All the patients were kept under a close follow-up for 6 weeks period and at the end of 12 weeks of medication, the safety and tolerability outcomes were assessed as per the operational definition.

Being tested
Sacubitril/valsartan
Medical subject headings
Heart Failure, Systolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacubitril/valsartanDrug

    Also called Angiotensin receptor blocker and neprilysin inhibitor (ARNI)

    All the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.

Study groups in NCT05387967
Study groupRoleWhat they receive
Treatment groupExperimentalAll the recruited patients were prescribed Sacubitril/Valsartan at a starting dose of 50 (24/26) mg BID which was up-titrated, over the period of initial 6 weeks, to the maximum tolerated dose up to 200 (97/103) mg BID and further followed for a total of 12 weeks.
Receives: Drug: Sacubitril/valsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of hypotension

    Systolic blood pressure <90 mmHg

    Measured: 12 weeks

  2. Incidence of renal dysfunction

    estimated glomerular filtration rate (eGFR) <30 ml/min

    Measured: 12 weeks

  3. Incidence of renal hyperkalemia

    Potassium >5.2 mmol/L

    Measured: 12 weeks

  4. Incidence of renal angioedema

    Rapid edema, or swelling, of the area beneath the skin or mucosa

    Measured: 12 weeks

  5. Frequency of tolerability

    Defined as the dose tolerated by the patients which did not require down titration or discontinuation of prescribed dose during follow-up

    Measured: During 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study start1 Jan 2021
  3. Primary completion30 Jun 2021
  4. Study completion30 Sep 2021

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label non-randomized clinical trial
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387967
Sponsor's protocol ID
ERC-05/2020
Status last verified
May 2022
First submitted
13 May 2022
Last updated
24 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khan MN, Soomro NA, Naseeb K, Bhatti UH, Rauf R, Balouch IJ, Moazzam A, Bashir S, Ashraf T, Karim M. Safety and tolerability of Sacubitril/Valsartan in heart failure patient with reduced ejection fraction. BMC Cardiovasc Disord. 2023 Mar 13;23(1):133. doi: 10.1186/s12872-023-03070-9.

    PubMed 36915075

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sacubitril/valsartan in people with Heart Failure, Systolic, run by National Institute of Cardiovascular Diseases, Pakistan 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 6 inclusion and 5 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 24 May 2022. 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.

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 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?

Incidence of hypotension (time frame: 12 weeks). The study lists 5 primary outcomes in all. 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 NCT05387967, which also lists 1 linked publication.

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 24 May 2022.

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