Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-blind, randomised, clinical trial assessing the efficacy of Hydralazine and Isosorbidedinitrate combination (oral agents) in HF patients with renal dysfunction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborators: Changi General Hospital; National Heart Centre Singapore; Singapore Clinical Research Institute
• Treatments: Hydralazine; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate

Criteria

Inclusion Criteria:

1. At least 21 years of age

2. Asian patients with symptomatic HF (regardless of EF) and renal impairment (eGFR<60ml/min/1.73m2)

3. At least one hospitalisation for HF during the preceeding year

4. On stable (at least 1 month) optimal medical therapy (maximum tolerated doses of ACE inhibitors or ARBs, beta blockers and aldosterone antagonists for HFREF, and optimally managed cardiovascular risk factors for HFPEF)

5. Able to complete 6 minute walk test (6MWT)

6. Able to maintain a systolic blood pressure ≥100mmHg

7. Able to provide written informed consent

Exclusion Criteria:

1. On chronic therapy with hydralazine and/or nitrates.

2. Known hypersensitivity to hydralazine and/or nitrates

3. Concurrent use of phosphodiesterase type 5 (PDE5) inhibitors

4. Females who are pregnant, nursing, or of childbearing potential and not practising effective contraception

5. Have had acute myocardial infarction, unstable or stable angina pectoris, or a cerebrovascular accident within the last 3 months

6. Have had cardiac revascularisation within the last 3 months or are likely to require coronary revascularisation within the study period

7. Have had cardiac arrest or life-threatening ventricular arrhythmia requiring intervention within 3 months

8. Rapidly deteriorating HF (2 admissions for acute decompensated HF, not due to non-compliance, within 6 months)

9. eGFR< 15ml/min/1.73m2, or on regular dialysis, or planned dialysis within the study period

10. Serious medical condition, emergency condition, uncontrolled systemic disease or any other medical condition that, in the judgement of the investigator, prohibits the patient from entering or potentially completing the study

11. Planned participation in any other interventional study or having received trial medication in the last 4 weeks within a clinical trial