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DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics
N/A
Waitlist Available
Research Sponsored by Revamp Medical Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline [t=0-12h] and through 24 hours [t=12-36h]
Awards & highlights
No Placebo-Only Group
Summary
The study objective is to observe and measure clinical outcomes, urine output, and safety events occurring during standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
Eligible Conditions
- Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline [t=0-12h] and through 24 hours [t=12-36h]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline [t=0-12h] and through 24 hours [t=12-36h]
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Serious Adverse Events
Serum Creatinine
Urine Output
Other study objectives
Dyspnea
Heart Failure Readmission
Length of hospitalization
+1 moreSide effects data
From 2007 Phase 4 trial • 552 Patients • NCT001108907%
Diarrhoea
7%
Vomiting
3%
Nausea
3%
Nasopharyngitis
3%
Muscle spasms
1%
Angina pectoris
1%
Myocardial infarction
1%
Pericarditis
1%
Chest discomfort
1%
Hernia
1%
Jaundice
1%
Gastroenteritis
1%
Arteriovenous fistula thrombosis
1%
Joint dislocation
1%
Joint injury
1%
Shunt occlusion
1%
Shunt thrombosis
1%
Blood potassium increased
1%
Fluid retention
1%
Hypovolaemia
1%
Pancreatic carcinoma
1%
Cognitive disorder
1%
Skin ulcer
1%
Catheter placement
1%
Hypertensive crisis
1%
Arteriovenous fistula occlusion
1%
Orthostatic hypotension
1%
Cardiac arrest
1%
Chest pain
1%
Pyrexia
1%
Cholecystitis
1%
Arthritis bacterial
1%
Bacterial sepsis
1%
Fall
1%
Back pain
1%
Pain in extremity
1%
Dyspnoea
1%
Nephrectomy
1%
Hypotension
1%
Peripheral ischaemia
1%
Atrial flutter
1%
Cardiac asthma
1%
Abdominal pain
1%
Sudden cardiac death
1%
Transplant rejection
1%
Perianal abscess
1%
Pneumonia
1%
Urinary tract infection
1%
Ankle fracture
1%
Arteriovenous fistula site complication
1%
Rib fracture
1%
Cerebral infarction
1%
Gastrointestinal haemorrhage
1%
Catheter related infection
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Care
Cinacalcet
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ADHF patientsExperimental Treatment1 Intervention
Patients with acute decompensated heart failure (ADHF) having insufficient response to diuretic therapy following a dose escalation protocol in keeping with AHA guidelines for the management of heart failure.
Find a Location
Who is running the clinical trial?
Revamp Medical Ltd.Lead Sponsor
2 Previous Clinical Trials
44 Total Patients Enrolled
2 Trials studying Heart Failure
44 Patients Enrolled for Heart Failure