| CTRI Number |
CTRI/2009/091/000713 [Registered on: 11/09/2009] |
| Last Modified On: |
10/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate performance of a non-invasive study device to monitor patients fluid status in congestive heart failure. |
|
Scientific Title of Study
|
Adherent Monitoring of Congestive Heart Failure during Therapy for Excess Fluid (ACUTE) Study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrVKChopra |
| Designation |
Senior Consultant Cardiologist |
| Affiliation |
Escorts Heart Institute and Research Center |
| Address |
Escorts Heart Institute and Research Center, Okhla Road
New Delhi
DELHI
110025
India |
| Phone |
91-9871699420 |
| Fax |
011-26825112 |
| Email |
chopravk@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jayshri Krishnan |
| Designation |
Dy Head Operations |
| Affiliation |
Max Neeman Medical International |
| Address |
Max Neeman Medical International
C/o Max Specialities, IIIrd Floor, New no. 6/ Old no. 34, Crown Court, Cathedral Road
Chennai
TAMIL NADU
600086
India |
| Phone |
9771407484 |
| Fax |
044-42036897 |
| Email |
jayashri.krishnan@maxneeman.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shariq Anwar |
| Designation |
Head Operations |
| Affiliation |
Max Neeman Medical International |
| Address |
Max Neeman Medical International
Max House, First Floor
1, Dr. Jha Marg, Okhla Phase III
New Delhi - 110020
Chennai
TAMIL NADU
600086
India |
| Phone |
09810979215 |
| Fax |
044-42036897 |
| Email |
Shariq.Anwar@maxneeman.com |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Corventis Inc |
| Address |
2226, North First St., San Jose, CA 95131. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.V.K.Chopra |
Escorts Heart Institute and Research Center, Okhla Road, New Delhi (India)-110 025 |
Escorts Heart Institute and Research Center,Okhla Road-110025
New Delhi
DELHI |
+91-9871699420
011-26825112
chopravk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Escorts Heart Institute and Research Centre, Room # 632,RC Building, Okhla Road, New Delhi-110025. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Congestive Heart Failure (CHF)
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Investigational non invasive monitoring device |
Not Applicable |
| Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Potential patients must meet all of the following criteria:
1. Is female or male, 18 years of age or older
2. Has an ejection fraction of 40% reported within 12 months of enrollment
3. Have acute decompensated heart failure and receiving treatment for fluid overload
4. Is willing to provide written informed consent and comply with study guidelines
|
|
| ExclusionCriteria |
| Details |
Patients will be excluded from the study if they meet any of the following criteria
1. Has an implantable device with an active minute ventilation sensor
2. Has a known allergy or hypersensitivity to adhesives or hydrogel
3. Has received the first treatment for this episode of acute heart failure decompensation more than 24 hours ago
4. Is participating in another clinical study that may confound the results of this study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To gather data to correlate physiological signals with the patient?s fluid status and heart failure symptoms during recovery from acute heart failure decompensation. |
Analyses in addition to the primary endpoint analysis will include:
ii) Summarizing the incidence and frequency of all adverse events reported during the study. Events will be classified by the study sites into adverse events, serious adverse events (SAEs), and/or unanticipated adverse device effects (UADEs). Severity of each event will be classified as mild, moderate or severe. The relationship to the investigational device will be determined using a classification of Definite, Probable, Possible or None. The number and percent of patients experiencing each event will be presented with the number and percent of the following: SAE, UADE, moderate events, severe events, definitely related events, probably related events and possibly related events.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
14/03/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
14/04/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, multi-center, non-randomized study. Patients who have been admitted to the hospital with fluid overload will be enrolled into the study and monitored with the investigational device for up to 2 weeks. The system will continuously record physiologic variables such as heart rate, fluid conductance, activity and respiration.
|