Haemodynamic Effects of Dobutamine in Patients with Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)

2023-508298-10-00 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 1 Apr 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 15
Countries 1
Sites 1

Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)

•To investigate the hemodynamic effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt, assessed simultaneously by right heart catheterization (RHC) and echocardiography. •To assess the safety of dobutamine infusion in ATTRwt patients.

Key facts

Sponsor
Region Midtjylland
Participant type
Patients
Age range
65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
1 Apr 2024 → ongoing
Decision date (initial)
2023-12-08
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2023-508298-10-00
WHO UTN
U1111-1295-8321

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Therapy

•To investigate the hemodynamic effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt, assessed simultaneously by right heart catheterization (RHC) and echocardiography.
•To assess the safety of dobutamine infusion in ATTRwt patients.

Conditions and MedDRA coding

Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. ATTRwt, diagnosis confirmed by genetic testing, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy and/or endomyocardial biopsy.
  2. Treated with loop diuretics.
  3. New York Heart Association (NYHA) class II-IV.
  4. Age ≥ 65 years.
  5. Left ventricular ejection fraction (LVEF) < 50 % and/or SVI assessed by echocardiography < 35 ml/m2.
  6. Informed consent.

Exclusion criteria 4

  1. Moderate to severe aortic stenosis (patients with aortic sclerosis will not be excluded).
  2. Other significant valvular diseases.
  3. Known severe coronary artery diseases: left main stem stenosis or 3-vessel disease, or recent acute myocardial infarction (< 4 weeks).
  4. Contraindications to the use of dobutamine: Known allergy to dobutamine or sulfite, phaeochromocytoma or ventricular tachycardia (VT).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. changes in CO evaluated by the thermodynamic invasive method.

Secondary endpoints 5

  1. Changes in SVI measured invasively
  2. Changes in PAWP and mPAP
  3. Changes in LVEF and LV-global longitudinal strain (LV-GLS)
  4. Correlation between echo- and invasive measured SVI, and CO
  5. Rate of complications/symptomatic side effects

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Dobutrex, koncentrat til infusionsvæske, opløsning

PRD5384371 · Product

Active substance
Dobutamine
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
IV INFUSION
Max daily dose
400 µg/Kg microgram(s)/kilogram
Max total dose
400 µg/Kg microgram(s)/kilogram
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
C01CA07 — DOBUTAMINE
Marketing authorisation
12973
MA holder
STADA NORDIC APS
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 2

Natriumklorid ”B. Braun”

PRD563912 · Product

Active substance
Sodium Chloride
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
40 ml millilitre(s)
Max total dose
50 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B05BB01 — ELECTROLYTES
Marketing authorisation
13341
MA holder
B.BRAUN MELSUNGEN AG
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Glukose Isotonisk "SAD", injektions- og infusionsvæske, opløsning

PRD371170 · Product

Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS USE
Max daily dose
50 ml millilitre(s)
Max total dose
50 ml millilitre(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B05BA03 — CARBOHYDRATES
Marketing authorisation
16154
MA holder
AMGROS I/S
MA country
Denmark
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

59 Total trials 36 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Region Midtjylland
Address
Palle Juul-Jensens Boulevard 99
City
Aarhus N
Postcode
8200
Country
Denmark

Scientific contact point

Organisation
Region Midtjylland
Contact name
Ali Hussein Jaber Mejren

Public contact point

Organisation
Region Midtjylland
Contact name
Ali Hussein Jaber Mejren

Third parties 1

OrganisationCity, countryDuties
Aarhus Universitet
ORG-100028380
 Aarhus N, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 15 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Region Midtjylland
Cardiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2024-04-01 2024-04-07

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) DobATTR protocol 4.0
Recruitment arrangements (for publication) Recruitment and informed consent procedure 2.0
Subject information and informed consent form (for publication) Consent form-Danish 1
Subject information and informed consent form (for publication) Deltagerinformation_dobAttr 3.0
Subject information and informed consent form (for publication) Dine rettigheder som forsgsperson i forsg med medicin 1
Summary of Product Characteristics (SmPC) (for publication) SmPC for Dobutrex 1
Synopsis of the protocol (for publication) Protokol synopsis 2.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-09-20 Denmark Acceptable
2023-12-07
 2023-12-08
2 SUBSTANTIAL MODIFICATION SM-1 2026-03-09 Denmark Acceptable
2026-04-17
 2026-04-19

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