Secondary Use of PARALLEL-HF Data (NCT07527767) | Clinical Trial Compass
CompletedNot Applicable
Secondary Use of PARALLEL-HF Data
Japan236 participantsStarted 2022-07-27
Plain-language summary
This study utilized the blood and first morning void (FMV) urine samples from the PARALLEL-HF study (core part). The PARALLEL-HF study (core part) was a multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to assess the effect of sacubitril valsartan at a target dose of 200 mg b.i.d. and enalapril 10 mg b.i.d. on cardiovascular (CV) mortality and morbidity in Japanese HF patients with reduced ejection fraction.
Who can participate
Age range
20 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written informed consent was required before any assessment could be performed.
. Male or female outpatients of ≥ 20 years of age (at the time of signing informed consent)
. Patients with a diagnosis of congestive heart failure NYHA class II-IV and reduced ejection fraction:
. Patients were to be on an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB) at a stable dose for at least 4 weeks before Visit 1.
. Patients were to be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to Visit 1.
. An aldosterone antagonist was also to be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist was to be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to Visit 1. Other evidence-based therapy for HF was also to be considered e.g., cardiac resynchronization therapy and an implantable cardioverter-defibrillator in selected patients, as recommended by guidelines.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
association between change in NYHA classification and change in plasma log BNP levels from Baseline
. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes, ACEIs, ARBs, neutral endopeptidase (NEP) inhibitors as well as known or suspected contraindications to the study drugs.
. Previous documented history of intolerance to ACEIs or ARBs.
. Known history of angioedema.
. Requirement of treatment with both ACEIs and ARBs.
. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
. Symptomatic hypotension and/or a systolic blood pressure (SBP) \< 100 mmHg at Visit 1 (Screening) or \< 95 mmHg at Visit 199 (end of run-in).
. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as measured by the Japanese formula at Visit 1 (Screening) or Visit 199 (end of run-in) or \> 35% decline in eGFR between Visit 1 and Visit 199 (according to local measurements).
. Serum potassium \> 5.2 mmol/L (mEq/L) at Visit 1 (Screening) or \> 5.4 mmol/L (mEq/L) at Visit 199 (end of run-in) (according to local measurements).