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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02343393
• Date of registration: 15/01/2015
• Prospective Registration: No
• Primary sponsor: National University Hospital, Singapore
• Public title: Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study NICHE
• Scientific title: Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study
• Date of first enrolment: January 2015
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02343393
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Singapore

Contacts

• Name: Su Ping Carolyn Lam, MBBS, MRCP, MS

• Name: Su Ping Carolyn Lam, MBBS, MRCP, MS
• Affiliation: National University Hospital, Singapore

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cardio-Renal Syndrome

Intervention(s)

Drug: Hydralazine

Drug: Isosorbide Dinitrate

Primary Outcome(s)

Effort tolerance by assessing 6 Minute Walk Test (6MWT) [Time Frame: 24 weeks]

Secondary Outcome(s)

Clinical outcomes by recording deaths and HF hospitalisations [Time Frame: 24 weeks]

Renal function (eGFR, Cystatin C, markers of kidney injury (proteinuria as quantified by urine protein-creatinine ratio (uPCR), NGAL)) [Time Frame: 24 weeks]

Quality of Life by self-reported 36-item Short Form Health Survey (SF-36) [Time Frame: 24 weeks]

Cardiac structure and function by 2D and Doppler echocardiography [Time Frame: 24 weeks]

Endothelial function as measured via a reactive hyperaemic index (RHI) by Peripheral Arterial Tonometry (PAT) [Time Frame: 24 weeks]

Secondary ID(s)

NICHE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Changi General Hospital

National Heart Centre of Singapore Pte Ltd

Singapore Clinical Research Institute